DRA details: President issues ordinance to form drug regulatory body

The agency will regulate pricing and quality of medicines produced in the country.

ISLAMABAD: President Asif Ali Zardari on Friday issued a much awaited ordinance to set up a centralised regulation body of the pharmaceutical industry.

The cabinet division issued notification for the consideration of the establishment of the agency on Friday under the Drug Regulatory Agency Ordinance (DRAO) 2012.

The notification has not been confirmed by the Presidency, but a cabinet division official confirmed to The Express Tribune on condition of anonymity that the notification has been issued.

The agency is to control pricing of drugs, quality assurance, import/export and issuing licences to drug manufacturers among other details.

According to official sources working closely with DRA, the head office of the agency will be based in Islamabad. It will work under the cabinet secretary and will be made up of 13 members, including all provincial health secretaries. The head of the agency will be a chief executive officer who should hold a postgraduate degree and 20 years experience. His tenure will be for three years and would be extended for another year if required. Besides this, one technical member will be taken from the federation, doctors, pharmacists and pharma industry.

The main hurdle behind the establishment of DRA was the Punjab government, which was initially reluctant to issue a no-objection certificate (NOC).

But the agency faces more opposition.

“The DRA has been established on the draft formulated by Nargis Sethi, not on the draft given by the special committee or the Parliament,” said Senator Abdul Haseeb from the Muttahida Qaumi Movement (MQM) while talking to The Express Tribune.

Haseeb, who has been the convener of the Senate special committee on formation of Drug Regulatory authority said, “The newly-introduced ordinance does not contain even a single thing proposed by the committee in its draft.” He added that the committee will not approve the DRA.

A senior official working closely with the Drug Registration Board (DRB) on condition of anonymity said that the newly-established agency will not operate for the purpose that it has been created.

He explained that this is because there are currently about 400 pharmaceutical units and about 70,000 drugs registered in the country. There is a huge shortage of staff available to keep a check on all these drugs. The staff in DRA would not be enough to look after all of these.

Also, the drug inspectors who are working under the Executive District Officer Health (EDOs), District Health Officer (DHOs) and hospital pharmacies working under the Medical Superintendent (MS) should work under the DRA and report to it directly.

This will give them authority and power to take action against illegal work as currently they are working under a lot of pressure, which usually stops them from taking any action.

He said that the government has violated the orders of the chief justice who in 2007 directed the government to give separate offices to the drug inspectors and also to provide them with a transport facility. He added that currently there are only 478 drug inspectors across the country, which is not enough. The drug inspector lacks staff with whom he can conduct raids. He goes alone without security or any protection.

Lack of facilities forces these employees to engage in corrupt activities, according to the official.

This Drug Regulatory Agency has only been created to fulfill corrupt motives of the cabinet secretary and her blue eyed boy Dr Orakzai. There is already another ministry (CAD) in Islamabad that controls health and educational intuitions of federal government, but this lucrative department has been handed over to the cabinet secretary who is very very close to the Prime Minister, as this department can make lot of illegal money. Secretary cabinet is being fed by Dr Orakzai who is an adopted son of an EX- Federal Secretary and before this he was involved with the project of Islamabad Medical College that was being established by the Pakistan Institute of Medical Sciences Islamabad, however because of his close relations with the Secretary Cabinet Dr Orakzai snatched that project from PIMS and took it to Cabinet division with him instead of CAD Ministry that controls PIMS and other federally funded health institutions.

This is not correct, we did have a Drug Regulatory Authority under Dug Control Organizaiotn in the Federal Ministry of health. The probem started on dissolution of ministry of health after 18th amendment.

We can make and develop independent instructions and authorities to run this country. But e are not sincere with ourself, we do not solve the problems faced by us and country, rather we leave the problems on others and just pass time. Now the things have started collapse down.

Unluckily no one from powerful desk is willing to sacrifice his/her wishes of influence in appointment of executives etc. for the benefit of public health and economy of country. Justics and honesty is the only solution

I would agree “Aonther Incomplete Mandate to Play with Health of Pakistanis”
only making DRA wouldn’t accomplish the goal to achieve transprancy and justification required for the Safety and Risk-Benefits balance involved with the Medicine, Biologicals, Biotechnology and Consumer Healthcare products (CHC even doesn’t regulated under any such body or Authority) in Pakistan;
I wish our DRA could work same alike an independant body as FDA of USA, MHRA of UK, BfArM of Germany and so many other bodies in the Pharmaceutical medicinal/Health world around the globe, working above from Beurocratic/political clutches and Red tapeism ….. but all wishes never come true??

Drug Regulatory Agency needs very professional team of people free of all kinds of political & beaurocratic influences & pressures.If people who do not understands the ABC of Pharmaceuticals regulations are inducted, then we should not expect much of this body. The main focus of this team should be total Quality. The present Drug Act 1976 covers all aspects of quality issues but unfortunately there is no professional attitude of the present set up, as a result of which there is no implementation of very important provisions of the Act.This body is needed not only in the federal govt for regulation of manufacturing, import & export rather it should also be declared at all provincial headquarters. At the movement drug regulations at the provincial level is just like an orphan dody which cannot deliver under the influence of EDOs who do not understands this subject. We should also not forget that this important Pharma sector has knowingly defamed & pushed backward despite the fact that this is the only sector which has shown a constant growth for the last one & half decade and which has accommodated hundred thousands of families for jobs.
I wish and hope the federal govt may decide & resolve this issue in a very professional manner for the promotion of this life saving sector.